BUNDLE: Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 7th edition – Print and Guidance

This combination provides two ways to access the 7th edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards): print and digital. This edition of MT Standards contains requirements for facilities using molecular methods to predict blood group antigens on red cells, platelets, and neutrophils, as well as quality system requirements, operational stan¬dards, and a detailed list of inventory resources necessary for the identification of targeted nucleotides that encode these antigens.

The 7th edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards) contains requirements for facilities using molecular methods to predict blood group antigens on red cells, platelets, and neutrophils, as well as quality system requirements, operational stan¬dards, and a detailed list of inventory resources necessary for the identification of targeted nucleotides that encode these antigens.

Organized according to the Quality System’s Essentials quality template, the MT Standards addresses operational aspects such as test methods including Restriction Fragment Length Polymorphism Testing, DNA Testing for Nucleotide Sequence Determination or Single Nucleotide Polymorphism (SNP) Analysis, and DNA Array. The guiding principle of this document is to be consistent with avail¬able scientific information while focusing on patient advocacy and opti¬mal care for donors. These MT Standards represent the minimum requirements under which a laboratory specializing in molecular testing should operate.

Significant Changes to the 7th Edition

• The updated Quality Systems Essentials template has been incorporated into the 7th edition, including updated language and new sections on key concepts, key terms, and examples of objective evidence.
• New Standards 2.1.3.1 and 2.1.3.2 provide details on what training should include and the qualifications of the trainer providing the training.
• Reference Standard 2.2A, Minimum DNA Resources, has been expanded to include all 45 red blood cell systems available to accredited molecular testing laboratories.
• New Standard 5.3.2 requires that laboratories using laboratory developed tests or research use only kits follow specified requirements.
• New Standard 5.3.2.3 ensures that investigational products are labeled appropriately.
• New Standard 5.6.2 requires that laboratories have a plan in place for the implementation of ISBT nomenclature antigens and alleles.

Guidance for Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens includes verbatim requirements from the 7th edition of MT Standards interspersed with guidance. Language from the MT Standards is presented; when there is appropriate guidance for that standard, the guidance language follows the standard with the heading “Guidance.” This format allows the reader to see both the requirement and the associated guidance side by side.

Please note that there is no guidance for some standards. The Molecular Testing Standards Commit¬tee has chosen to focus MT Standards on those issues that may require additional context and/or examples to assist in attaining compliance with the Standards. 

Effective date: January 1, 2025

BUNDLE: AABB, 2024, 116 pages, ISBN 978-1-56395-516-7 and AABB, 2024, 90 pages

Product Code: 244205
AABB Member Price: $233
Nonmember Price: $267

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)